MALARIA: trial of azithromycin and chloroquine fixed-dose combination in pregnant women in Africa

Abstract (provisional)

Background

Malaria in pregnancy is one of the most common preventable causes of maternal and neonatal morbidity and mortality in sub-Saharan Africa. To prevent its adverse effects, such as maternal anaemia, placental parasitaemia and low birth weight (LBW) neonates, the World Health Organization recommends effective malaria case management, use of insecticide-treated bed nets and intermittent preventive therapy in pregnancy (IPTp). Sulphadoxine-pyrimethamine (SP) has been the standard for IPTp in several countries, but parasite resistance to SP is growing. Therefore, new IPTp therapies are urgently needed. One candidate being evaluated for IPTp is a fixed-dose combination of azithromycin and chloroquine (AZCQ). This paper describes the challenges and the innovative solutions implemented in designing and conducting a pivotal AZCQ-IPTp trial, sponsored by Pfizer Inc and co-funded by Pfizer Inc and the Medicines for Malaria Venture.

Results

This study is ongoing and expected to complete in 2014.

Conclusion

This report describes the unique challenges and innovative solutions implemented in designing and conducting this pivotal AZCQ-IPTp trial, which may serve as a prototype for future IPTp and other studies involving similar conditions.

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About Me

After service in the British SAS Regiment the author became a physician and then an orthopaedic surgeon.
He has held professorial positions in Canada, Vietnam and the United States, practiced and taught orthopaedic surgery in three continents and in several wars.
He has extensive experience as an expert witness in court. Somewhere along the way, time was found to operate a four hundred acre mixed farm, a one hundred seat restaurant and to obtain a licence as a flying instructor.
The author's books are available from bookstores, the publishers, or from on-line bookstores such as Amazon, Barnes and Noble, and Indigo/Chapters.
http://mclementhall.com